Actively Recruiting
The 8x5 Diet for Bile Acid Diarrhoea: A Feasibility Randomised Controlled Trial
Led by University of Manchester · Updated on 2024-12-16
76
Participants Needed
1
Research Sites
51 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Bile acid diarrhoea is a common cause of chronic watery diarrhoea. Treatment is life-long medication. However, about 50% of people have ongoing, bothersome diarrhoea. Findings from recent research on diet therapies and food intolerances have been used to develop a healthy dietary pattern called The 8x5 Diet. We will test the practicalities of conducting a randomised controlled trial of this dietary intervention.
CONDITIONS
Official Title
The 8x5 Diet for Bile Acid Diarrhoea: A Feasibility Randomised Controlled Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older, of any ethnic group, living in the United Kingdom and not planning to move in the next three months
- Self-reported diagnosis of bile acid diarrhoea confirmed by 7-day SeHCAT testing
- Self-reported ongoing chronic diarrhoea despite appropriate medication
- Able and willing to stay in the assigned diet group for the 8-week study period
- Body mass index of 20 kg/m2 or higher
- Able to communicate in English or via a carer without an interpreter using a computer, smartphone, or tablet
- Able to provide informed written consent
- Able to provide the address of their general practitioner to notify participation
You will not qualify if you...
- Unable to confirm diagnosis of bile acid diarrhoea by SeHCAT testing
- Pregnant, breastfeeding, or planning pregnancy within six months
- Having inflammatory bowel disease, microscopic colitis, liver disease, pancreatic disease, AIDS/HIV, cancer radiotherapy, or other serious illnesses
- Having diarrhoea that is not active enough (less than 3 stools per day or less than 1 watery stool per day on average over one week)
- Currently participating in another research study or participated in the last 3 months
- Using insulin, metformin (other than slow-release), anti-obesity medication, or meal replacement supplements in the last 3 months
- Use of antibiotics in the last 4 weeks
- Having food allergies other than oral allergy syndrome/pollen-food syndrome
- Having dietary exclusions such as gluten, lactose, biogenic amines, or refusing to eat key food groups like starchy foods, fruits, vegetables, proteins, or dairy
- Having an active or recent eating disorder or disordered eating in the past 12 months
- History of alcohol or drug abuse, self-harm, depression, or suicide thoughts in the past 12 months
- Being a shift worker
- Unwilling to keep a weighed 7-day food diary
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Yvonne McKenzie
Manchester, Greater Manchester, United Kingdom, M13 9PL
Actively Recruiting
Research Team
Y
Yvonne McKenzie, MSc
CONTACT
S
Sorrel Burden, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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